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Showing 20261–20280 of 22584 results

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Anika Therapeutics, Inc.: Amvisc Plus Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc...

Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

FDAJul 14, 2005CA, NC• Anika Therapeutics, Inc.

Anika Therapeutics, Inc.: Amvisc Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Ro...

Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

FDAJul 14, 2005CA, NC• Anika Therapeutics, Inc.

Anika Therapeutics, Inc.: Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. S...

Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

FDAJul 14, 2005CA, NC• Anika Therapeutics, Inc.

Anika Therapeutics, Inc.: Amvisc Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Ro...

Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

FDAJul 14, 2005CA, NC• Anika Therapeutics, Inc.

Anika Therapeutics, Inc.: ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Ste...

Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

FDAJul 14, 2005CA, NC• Anika Therapeutics, Inc.

Baxter Healthcare Renal Div: Accura System for Blood Filtration, product codes 5M5660 ...

In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart therapy

FDAJul 13, 2005Nationwide• Baxter Healthcare Renal Div

Sammons Preston Rolyan, An Ability One Company: TM-300 Traction System; an Rx software driven device used...

The traction device may malfunction, producing oscillation and a jerking motion.

FDAJul 13, 2005Nationwide• Sammons Preston Rolyan, An Ability One Company

ArthroCare Corporation: ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula ...

Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection

FDAJul 12, 2005IL, IN, MD +8 more• ArthroCare Corporation

Medtronic Emergency Response Systems, Inc.: Hard shell carry case for the LIFEPAK 500 AED.

Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).

FDAJul 12, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Becton Dickinson & Company: BD Vacutainer Blood Transfer Device. It consists of a Lu...

Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.

FDAJul 11, 2005Nationwide• Becton Dickinson & Company

Teleflex Medical: Rusch/MMG Urinary Catheterization System, 14 Fr; the sing...

There is a lack of assurance of sterility for parts of these lots of product.

FDAJul 11, 2005Nationwide• Teleflex Medical

JK Products & Services, Inc: SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet...

The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord.

Class IIModerate

FDAJul 8, 2005Nationwide• JK Products & Services, Inc

JK Products & Services, Inc: SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet...

The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord.

FDAJul 8, 2005Nationwide• JK Products & Services, Inc

Dade Behring Inc.: Coagulation Factor VIII Deficient Plasma (OTXW). Factor D...

sample may exhibit falsely high results

FDAJul 8, 2005AZ, AR, CA +21 more• Dade Behring Inc.

Beckman Coulter Inc: Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.

FDAJul 6, 2005Nationwide• Beckman Coulter Inc

Baxter Healthcare Corp. Rt.: Baxter Interlink System Y-Type Minivolume Extension Set, ...

Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.

FDAJul 6, 2005AZ, GA, IL +5 more• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Interlink System Minivolume Extension Set, product...

Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.

FDAJul 6, 2005AZ, GA, IL +5 more• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Healthcare Corporation, Medication Delivery Divisi...

During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attempting to turn on the device by pressing the On/Off key, the pump may not power up properly.

FDAJul 6, 2005Nationwide• Baxter Healthcare Corp. Rt.

Guidant Cardiac Surgery: Aortic Cutter, single use device consisting of grip, cutt...

Laceration Risk

Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device

FDAJul 5, 2005FL, MO, NE +1 more• Guidant Cardiac Surgery

Medtronic Neurosurgery: Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer S...

Cracked hubs/handles and/or improper peeling of the sheath during use.

FDAJul 5, 2005Nationwide• Medtronic Neurosurgery

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